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U.S. Department of Health and Human Services

Drugs

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CDER Priority Drug and Biologic Approvals: Calendar Year 2009

 

As of December 31, 2009

 

Selection Criteria:
User Response: Start Date: 1/1/2009 12:00:00 AM End Date: 12/31/2009

Sort Order: Approval Date

Last Refresh Date: 5/25/2010

 

Application NumberProprietary NameEstablished NameApplicantReview ClassificationApproval Date
NDA 022278MEMBRANEBLUEMEMBRANEBLUE 0.15% TRYPAN BLUE OPHTHALMIDORC INTERNATIONAL BVP2/20/2009
NDA 022334AFFINITOREVEROLIMUSNOVARTIS PHARMACEUTICALS CORPP3/30/2009
NDA 022268COARTEMARTEMETHER 20MG LUMEFANTRINE 120MGNOVARTIS PHARMACEUTICALS CORPP, O4/7/2009
NDA 020725CREON/ MINIMICROSPHERE) PANCRELIPASE D-R CPANCRELIPASE DELAYED RELEASE CAPSSOLVAY PHARMACEUTICALSP4/30/2009
NDA 022348CALDOLOR INJECTIONIBUPROFEN INJECTIONCUMBERLAND PHARMACEUTICALS INCP6/11/2009
NDA 022315OZURDEXDEXAMETHASONE BIODEGRADABLE INTRAVITREALALLERGAN INCP6/17/2009
NDA 022425MULTAQDRONEDARONE HCLSANOFI AVENTIS US LLCP7/1/2009
NDA 022307EFFIENTPRASUGRELELI LILLY AND COP7/10/2009
NDA 022352COLCRYS TABLETS 0.6 MGCOLCHICINE TABLETS USP 0.6 MGAR HOLDING CO INCP, O7/29/2009
NDA 022321EMBEDAMORPHINE SULFATE ER W SEQUESTERED NALTREALPHARMA PHARMACEUTICALS LLC KING PHARMACEUTICALSP8/13/2009
NDA 022006SABRIL (VIGABATRIN)VIGABATRINLUNDBECK INCP8/21/2009
NDA 022210ZENPEP PANCREATIC ENZYME PRODUCT DELAYED RELEAEEURAND INCP8/27/2009
NDA 022257VALCYTEVALGANCICLOVIR HYDROCHLORIDEROCHE PALO ALTO LLCP8/28/2009
NDA 022142EVAVIRENZ/ LAMIVUDINE/ TENOFOVIR DISOPROXIL FUMARATE FDC TABS (600MG/ 300MG/ 300MG) EVAVIRENZ/ LAMIVUDINE/ TENOFOVIR DISOPROXIL FUMARATE FDC TABS (600MG/ 300MG/ 300MG) MATRIX LABORATORIES LTDP9/3/2009
NDA 022468FOLOTYNPRALATREXATE INJECTION 20MG/1ML40MG/2MLALLOS THERAPEUTICS INCP,O9/24/2009
NDA 022430LYSTEDATRANEXAMIC ACID TABLETS, 650 MGXANODYNE PHARMACEUTICS INCP11/13/2009

 

Biologic License Application (BLA) Approvals: 

BLA NUMBERPROPRIETARY NAMEPROPER NAMEAPPLICANTREVIEW CLASSIFICATIONAPPROVAL DATE
L 125319/0.0CANAKINUMABILARISNOVARTIS PHARMACEUTICALS CORPORATIONP,O6/17/2009
L 125326/0.0OFATUMUMABARZERRAGLAXO GROUP LIMITED D/B/A GLAXOSMITHKLINEP,O10/26/2009
L 125277/0.0ECALLANTIDEKALBITORDYAX CORP.P,O12/1/2009

Review Classification:
P - Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
S - Standard Review - Products that do not qualify for priority review.
O - Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

 

This information has been provided by CDER/OPI/OBI/Division of Business Analysis and Reporting (DBAR).